Product code HKO— Ophthalmic

ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540

Classification name
Refractometer, Ophthalmic
Device class
Class 1
Regulation
21 CFR 886.1760
Advisory panel
Ophthalmic
Total cleared
35
First cleared
Most recent

Market context for product code HKO

FDA has cleared 35 devices under product code HKO between 1977 and 2003, filed by 19 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code HKO

Recent clearances under product code HKO

Data sourced from openFDA. This site is unofficial and independent of the FDA.